CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s spring virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what’s going on with the development of SEND and its use in regulatory submissions.
27 April, 2022 8:50am – 12:00pm EDT
Agenda
8:50am – 9:00am Introductions – CDISC SEND Leadership Team
9:00am – 9:15am AMED (Japan Agency for Medical Research and Development) - The SEND Discussion Team (among PMDA, Academia, and Industry in Japan)
- Status Presentation
9:15am – 10:15am Industry questions submitted to eData mailbox (FDA Panel)
- Answer questions compiled by CDISC SEND team and submitted via eData (e.g., compliance with SEND scope, sdTCG questions) (30 Minutes)
- Ask the Industry from the FDA – FDA has posed questions for discussion by industry members of the SEND Team (30 minutes)
10:15am – 10:45am FDA CDER OBI Presentation
- FDA eData Team /Technical Rejection Criteria Presentation
- Answer any industry questions submitted to the eData mailbox,as appropriate (TBD)
10:45am – 10:55am Break
10:55am – 11:15am CDISC-SEND Leadership Presentation
- SEND Release Schedule (Ben Sefing)
11:15am – 12:00pm Industry Sponsor Presentation
- BioCelerate Update (Mark Carfagna)
Connection Instructions:
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Meeting ID: 161 390 9710
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